FDA Recalls DeRoyal CNRV Spinal Pack Medical Devices
DeRoyal has voluntarily recalled 69 kits of CNRV Spinal Pack medical devices distributed to 23 US states. The manufacturer initiated the recall on November 3, 2022.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall for a surgical spinal pack, which is inherently a risk-of-harm product. No illnesses or injuries are reported in the source documentation. Per the severity rubric, risk-of-harm products without reported injuries qualify for score 3.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of 69 kits of the CNRV SPINAL PACK medical device (reference 89-10532.03) on November 3, 2022. The affected lot numbers are Lot 57188745 (expires 3/1/2024), Lot 57393378 (expires 5/1/2024), and Lot 57663075 (expires 5/1/2024). The FDA classified this as a Class II recall.
The devices were distributed across 23 US states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
Healthcare facilities and providers who have received these devices should contact DeRoyal Industries Inc or the FDA with any questions or for recall instructions. The recall remains ongoing.
The recalled product
- Product
- DeRoyal CNRV SPINAL PACK, REF 89-10532.03
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Spinal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: Lot 57188745 exp 3/1/2024
- Lot 57393378 exp 5/1/2024
- Lot 57663075 exp 05/01/2024
Distribution
Distribution scope not specified by the agency.
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